In a dramatic sequence of events that unfolded over just four days in early February 2026, online health and wellness company Hims & Hers launched, defended, and then abruptly withdrew a compounded version of Novo Nordisk’s newly approved Wegovy (semaglutide) pill for obesity. The episode exposed deep tensions between compounding pharmacies, branded pharmaceutical manufacturers, and federal regulators and raised fundamental questions about how far companies can push the boundaries of drug compounding law in the lucrative GLP-1 weight-loss market.
Hims Launches a $49 Compounded Wegovy Pill
On Thursday, February 5, 2026, Hims & Hers announced it would begin offering a compounded semaglutide pill starting at just $49 per month, with subsequent months priced at $99. The timing was striking: Novo Nordisk’s FDA-approved Wegovy pill had launched barely a month earlier on January 5, with a starting cash price of $149 per month and $199 per month thereafter. About 170,000 people had already purchased the branded pill in its first few weeks on the market.
Hims said its compounded version featured “a specialized formulation that is engineered to protect the active ingredient through digestion and support absorption,” using what the company described as “liposomal technology.” Notably, this was a different delivery mechanism than Novo Nordisk’s proprietary SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) technology, which the Danish drugmaker had spent years developing and testing in clinical trials to ensure the body could properly absorb the oral semaglutide.
The announcement also arrived just hours before President Trump unveiled TrumpRx.gov, a government-run website designed to connect cash-paying patients with drugmakers’ direct-purchasing channels. Novo’s Wegovy pill was prominently featured on the site, making Hims’ aggressive pricing strategy all the more conspicuous.
Novo Nordisk and Scientific Critics Push Back
Novo Nordisk responded swiftly and forcefully. In a statement, the company accused Hims of attempting to “unlawfully mass-market an unapproved, inauthentic, and untested knockoff semaglutide pill,” calling the move “illegal mass compounding that poses a significant risk to patient safety.” Novo pledged to take “legal and regulatory action to protect patients, our intellectual property and the integrity of the US gold-standard drug approval framework.”
On a call with analysts that same day, Novo Nordisk CEO Mike Doustdar argued that consumers would be “wasting $49” on the Hims product because, without Novo’s proprietary SNAC technology, the pill “just simply doesn’t work.” Former FDA Commissioner Dr. David Kessler echoed these concerns, noting in an interview that Hims was using “a different technology” with no publicly available clinical trial data to demonstrate efficacy. “This was not a copy,” Dr. Kessler said. “I’m not aware of any clinical trial data that suggests that the product that they wanted to sell actually worked.”
However, the legal picture was not entirely one-sided. Legal experts in pharmacy compounding law noted that what Hims was doing may have been permitted under the Food, Drug, and Cosmetic Act (FDCA).
Exception to the “Essentially a Copy” Prohibition Under the FDCA
Pursuant to section 506E of the FDCA, a compounding pharmacy may lawfully compound “essentially a copy” of a branded drug only if the drug is listed on the FDA’s drug shortage list. This was the case with semaglutide and tirzepatide until last year.
When there is no shortage, compounding pharmacies are prohibited from compounding “essentially a copy” of a branded drug, with one exception. Under the single, narrow exception, a pharmacy may compound what would otherwise be deemed “essentially a copy” if the compounded drug contains a change made for an identified individual patient, which produces for that patient a significant difference as determined by the prescribing practitioner, as compared to the branded drug.
There are numerous technical and administrative requirements that must be met in order to fit within this exemption. These can include dosage strength, concentration, weekly dose, route of administration, combination with other active ingredients and prescriber documentation. A compounded GLP-1 drug produced in compliance with all the requisite criteria may be lawfully prescribed and dispensed.
It is this exception to the prohibition to making “essentially a copy” of a branded drug that Hims & Hers was attempting to exploit with their compounded semaglutide pill.
The FDA Intervenes
The most consequential response came from the FDA. On the evening of February 5, FDA Commissioner Dr. Marty Makary posted on X that the “FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.” He emphasized that “the FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.” The agency also issued a news release indicating that Hims would be among the companies subject to scrutiny.
The following day, February 6, the top lawyer for the Department of Health and Human Services, Mike Stuart, escalated the situation further by announcing on X that his office had referred Hims to the Justice Department for potential violations of federal law governing the sale of medications.
The FDA’s position was consistent with the agency’s broader enforcement posture. In September 2025, the agency had already issued a Warning Letter to Hims objecting to “false or misleading” marketing claims on its website related to compounded GLP-1 injections. FDA Commissioner Makary had also published a JAMA editorial accusing Hims of a “breach of FDA regulation” with its 2025 Super Bowl advertisement, which promoted weight-loss drugs without adequately disclosing side effects.
Hims Reverses Course
On Saturday, February 7, just three days after the initial launch announcement, Hims & Hers announced it would stop selling the compounded Wegovy pill. In a statement, the company said the decision was made after “constructive conversations with stakeholders across the industry.” The company did not elaborate on the specifics of those conversations or address the Justice Department referral.
The withdrawal marked a notable retreat for a company that had aggressively expanded its GLP-1 business. Hims reported it was on pace to generate $725 million in revenue in 2025 from a weight-loss drug category that included both brand-name and compounded products. The company had spent $681 million on marketing in just the first nine months of 2025 and was widely believed to be the largest provider of compounded weight-loss medications in the United States.
Broader Implications for the GLP-1 Compounding Market
The episode underscores the ongoing tension at the center of the GLP-1 compounding debate. Traditional pharmacy compounding has existed for decades as a small-scale practice allowing pharmacists to customize medications during shortages or for patients with specific medical needs, such as allergies. However, the explosive consumer demand for semaglutide and tirzepatide weight-loss drugs has transformed compounding into a multibillion-dollar industry operating at a scale never originally envisioned by regulators.
During the semaglutide shortage, the FDA allowed compounding pharmacies to produce “essentially a copy” of Novo Nordisk’s Wegovy and Mounjaro. The shortage ended in the spring of 2025 and compounding pharmacies were once again banned from making compounded drugs based on semaglutide unless they fit the very narrow exception described above. Nevertheless, companies like Hims have continued selling compounded versions by adding vitamins, tweaking dosages, or altering delivery methods, arguing these modifications qualify as “personalization” under the exception to the “essentially a copy” prohibition. The Wegovy pill was never in shortage, making the compounding justification even more legally vulnerable.
Critics warned that if Hims’ compounded copy of the Wegovy pill had been allowed to stand, it would have set a dangerous precedent that could discourage pharmaceutical companies from investing in the costly research and development needed to bring new drugs to market. If any company could immediately produce and sell its own version of patent-protected medication without conducting clinical trials, the entire drug approval framework could be undermined. At the same time, the controversy highlights the immense consumer appetite for affordable weight-loss medications.
Novo Nordisk’s stock has plummeted from its mid-2024 peak, and the company has lost significant market share to both Eli Lilly’s competing drug Zepbound and to compounding providers. The broader question of how to balance drug innovation incentives with patient access and affordability remains far from resolved.
Conclusion
The rapid rise and fall of Hims’ compounded Wegovy pill in February 2026 has been one of the most dramatic episodes yet in the ongoing battle over GLP-1 compounding. The speed of regulatory intervention, from FDA warnings to a Justice Department referral within 48 hours, signals that federal authorities may be prepared to draw harder lines around mass compounding, even as the legal framework remains ambiguous. What is clear is that the competition for consumers in the weight-loss drug market shows no signs of slowing down.
The attorneys at Frier Levitt regularly assist compounding pharmacies in remaining compliant in what is oftentimes a complex and confusing regulatory environment. This includes advising clients on compliance matters related to compounding GLP-1s and peptides.
Frier Levitt regulatory attorneys experienced in FDA law and pharmacy law are available to assist clients with strategic advisory, regulatory compliance and enforcement defense services in the GLP-1, compounded drug and peptide space as regulations and enforcement in this sector continues to evolve.
Sources
Kansteiner, F. “FDA’s Makary pledges crackdown on mass marketing of ‘illegal copycat drugs’ in wake of Hims’ Wegovy pill push.” Fierce Pharma, February 6, 2026.
Robbins, R. “Facing Regulatory Scrutiny, Hims & Hers Withdraws Knockoff Obesity Pill.” The New York Times, February 7, 2026.
Livingston, S. “Novo’s threat to sue Hims over Wegovy pill faces legal hurdle.” Endpoints News, February 5, 2026.
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